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Rifaximin

Phase 2

Crohn's Disease | Small molecule | Immunology |Bausch + Lomb Corporation|Last Updated: Dec 9, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00603616Induction of Clinical Response Using Rifaximin in Crohn's DiseasePHASE2 COMPLETED 36Nov 1, 2008Nov 3, 2020Dec 9, 20211 United States
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Study Endpoints
Primary Endpoints
Evaluate the efficacy of rifaximin 550 mg bid compared to placebo in achieving clinical response in moderate to severe Crohn's Disease (CD) subjects as determined by a > 100 point decrease in the Crohn's Disease Activity Index (CDAI)
8 weeks
Secondary Endpoints
Evaluate the efficacy of rifaximin compared to placebo at inducing clinical remission in CD subjects
8 weeks
Evaluate the safety profile of rifaximin in subjects with active CD
16 weeks for those subjects who do not cross over, 32 weeks for those who do cross over
Evaluate the effect rifaximin has on the quality of life in subjects with CD compared to placebo
8 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1PLACEBO_COMPARATORPlacebo pills
2ACTIVE_COMPARATORRifaximin
Interventions
NameTypeDescription
Placebo ComparatorDRUGMatching oral placebo pills to be taken twice daily for a total of 8 weeks
RifaximinDRUGOral rifaximin 550mg to be taken twice daily for a total of 8 weeks
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female subjects, 18 to 80 years of age, inclusive, that can themselves provide written, informed consent and authorization of use of protected health information prior to any study-related procedures and who are, in the opinion of the investigator(s), likely to comply ...

Countries:United States
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